Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer
Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer
复制标题
DOI：
10.1200/jco.1999.17.8.2355
复制
发表时间：
1999-08-01
影响因子：
45.3
通讯作者：
Canetta, R
中科院分区：
文献类型：
--
作者：
Bishop, JF;Dewar, J;Canetta, R
目的：确定紫杉醇单药与非蒽环类联合化疗作为转移性乳腺癌一线治疗的位置。患者和方法：既往未经治疗的转移性乳腺癌患者随机接受紫杉醇200 mg/m2静脉注射（IV）3小时，共8个周期（24周）或标准环磷酰胺100 mg/m2/d口服第1 - 14天，甲氨蝶呤40 mg/m2 IV第1和8天，氟尿嘧啶600 mg/m2 IV第1和8天，结果：共209例患者随机分为紫杉醇组和泼尼松组，紫杉醇组中位生存期为17.3个月，泼尼松组中位生存期为13.9个月。多变量分析显示，接受紫杉醇治疗的患者生存时间明显长于接受CMFP治疗的患者（P = 0.025）。与CMFP相比，Paclitazone显著减少了严重的白细胞减少、血小板减少、粘膜炎、记录的感染（P均<0.001）、恶心或呕吐（P = 0.003）和发热（P = 0.007），并减少了因发热性中性粒细胞减少而住院的次数（P = 0.001）。紫杉醇组的脱发、周围神经病变、肌痛或关节痛更严重（均P <0.0001）。总体而言，两种治疗的生活质量相似（P大于或等于0.07）。结论：与CMFP相比，初始紫杉醇与骨髓抑制显着减少和感染减少相关，生存期更长，生活质量和转移性乳腺癌控制相似。(C)1999年，美国临床肿瘤学会。
Purpose: To determine the place of single-agent paclitaxel compared with nonanthracycline combination chemotherapy as front-line therapy in metastatic breast cancer.Patients and Methods: patients with previously untreated metastatic breast cancer were randomized to receive either paclitaxel 200 mg/m(2) intravenously (IV) over 3 hours for eight cycles (24 weeks) or standard cyclophosphamide 100 mg/m(2)/d orally on days 1 to 14, methotrexate 40 mg/m(2) IV on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8, and prednisone 40 mg/m2/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin recommended as second-line therapy.Results: A total of 209 eligible patients were randomized with a median survival duration of 17.3 months for paclitaxel and 13.9 months for CMFP. Multivariate analysis showed that patients who received paclitaxel survived significantly longer than those who received CMFP (P = .025). Paclitaxel produced significantly less severe leukopenia, thrombocytopenia, mucositis, documented infections (all P < .001), nausea or vomiting (P = .003), and fever without documented infection (P = .007), and less hospitalization for febrile neutropenia than did CMFP (P = .001). Alopecia, peripheral neuropathy, and myalgia or arthralgia were more severe with paclitaxel (all P < .0001). Overall, quality of life was similar for both treatments (P greater than or equal to .07).Conclusion: Initial paclitaxel was associated with significantly less myelosuppression and fewer infections, with longer survival and similar quality of life and control of metastatic breast cancer compared with CMFP. (C) 1999 by American Society of Clinical Oncology.